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Melatonin as an Analgesic in Preterm Neonate

A

Ain Shams University

Status

Enrolling

Conditions

Preterm Neonate Analgesia

Treatments

Drug: Melatonin 10 mg

Study type

Observational

Funder types

Other

Identifiers

NCT05971485
FMASU MS 496/2022

Details and patient eligibility

About

Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with several important functions, including regulation of the circadian rhythms, and antioxidant and anti-inflammatory effects, accumulating evidence revealed that it also plays an important role in pain modulation through multiple mechanisms. The investigators aimed to evaluate the analgesic effect of melatonin during venous cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure, and to demonstrate the significant relationship between procedural pain and Malondialdehyde (MDA), a well-accepted marker of oxidative stress through measuring MDA after 60 minutes of the procedure.

Enrollment

40 estimated patients

Sex

All

Ages

Under 28 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Preterm infant
  • less than 37 weeks gestational age
  • who started enteral feeding.

Exclusion criteria

  • Multiple congenital anomalies.
  • Facial malformation.
  • Receiving analgesia or sedation.
  • Contraindication of enteral feeding.
  • Clinical or laboratory signs of sepsis.
  • Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.

Trial design

40 participants in 2 patient groups

Melatonin group
Description:
Preterm neonates will receive melatonin 30 minutes before the venous cannula insertion.
Treatment:
Drug: Melatonin 10 mg
Control group
Description:
Preterm neonates will undergo venous cannula insertion without giving melatonin before the procedure.

Trial contacts and locations

1

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Central trial contact

Hebatallah Shaaban, MD

Data sourced from clinicaltrials.gov

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